Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer

September 17, 2023 updated by: Nashwa Radwan, Egyptian Atomic Energy Authority
To evaluate the using of a commercial product of dried human amniotic membrane sterilized by gamma irradiation for the treatment of skin ulcer.

Study Overview

Status

Completed

Conditions

Detailed Description

Dried human amniotic membrane patches were obtained from National center for radiation research and technology, Egypt, under commercial name REGE pro.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 29
        • Amniotic tissue lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study is based on randomized selection of 3 types of ulcer ( diabetic foot ulcer, post operative ulcer and ultrasonic ulcer)

Description

Inclusion Criteria:

  • patients have unhealing ulcer

Exclusion Criteria:

  • must stop other line of treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Size of ulcer
Time Frame: 2 week
REGE pro decreased size of ulcer after second treatment
2 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of pain
Time Frame: 1 week
Patients response revealed reduction of pain at the time of application. One week post application, a questionnaire were collected from patients; about 95% of them ensured that pain was controlled.
1 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete curring
Time Frame: 4 to 10 weeks
REGE pro healed ulcer after 4 to 10 weeks. The improvement of ulcer was observed by photographs taken before and each week post application.
4 to 10 weeks
Freedom from scarring
Time Frame: 10 weeks
It was observed that the using of REGE pro prevent any scar formation in all applied patients.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egyptian Atomic Energy Authority

Collaborators

Waleed Nemr,Egyptian Atomic Energy Authority

Investigators

  • Study Director: Nashwa K Radwan, PhD, NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

December 30, 2017

First Submitted That Met QC Criteria

February 19, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 17, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29112017NCRRT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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